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BIOINDUSTRY INITIATIVE

Department of State
September 16, 2004

Overview

The BioIndustry Initiative's mission is to counter the threat of bioterrorism through targeted transformation of former Soviet biological weapons research and production capacities.

The U.S. Department of State BioIndustry Initiative (BII) is a nonproliferation program authorized in the Defense and Emergency Supplemental Appropriations Act for FY 2002 (Public Law 107-117). BII focuses on two objectives:

-- The reconfiguration of former Soviet biological weapons (BW) production facilities, their technology and expertise for peaceful uses.

-- The engagement of Soviet Biological and Chemical Weapons scientists in collaborative R&D [research and development] projects to accelerate drug and vaccine development for highly infectious diseases.

Strategy

BII focuses on peaceful, transparent and ultimately self-sustainable redirection of biological research and production facilities in the former Soviet Union. BII facilitates partnerships between U.S. pharmaceutical companies and their Russian counterparts; utilizes consultation of both western and Russian marketing, business and engineering experts to assess and characterize core capabilities and strategic planning for the institutes; and develops skills and infrastructure required for a viable biotech sector in Eurasia. BII is a unique U.S. Government program providing patenting, commercialization, training, and business and market development for both the research institutes and large-scale production facilitates in the former Soviet Union.

Targeted Transformation of BW Capacities

By fostering new partnerships and diversifying funding sources, BII hopes to achieve its long-term goal of transforming former BW facilities into viable research and production institutions. BII engages specific institutes, assesses their core capabilities as well as the appropriate domestic and international market, then pairs Russian laboratories with American researchers in both academic and industrial sectors. BII may also fund projects in support of U.S. and Russian partnerships where promising technologies offer alternative routes to research and development. BII brings intensive partnering and facilitation through marketing, legal and business expertise to both the institute and the individual scientist. This strategy allows the institute to decrease the reliance on nonproliferation funding sources while increasing transparency on a defined pathway toward greater self-sustainability.

BII Funding

The BioIndustry Initiative's initial funding was authorized in the Department of Defense and Emergency supplemental appropriations for Recovery from and Response to Terrorist Attacks on the United States Act, 2002 (P.L. 107-117), Division B - Fiscal Year 2002 supplemental appropriations, Chapter 3. This appropriation transferred $30,000,000 to the Department of State, Nonproliferation, Anti-terrorism, Demining, and Related Programs "for the purpose of supporting expansion of the Biological Weapons Redirect and International Science and Technology Centers programs, to prevent former Soviet biological weapons experts from emigrating to proliferant states and to reconfigure former Soviet biological weapons production facilities for peaceful uses."

BII also receives annual funding through the U.S. Department of State's Office of Proliferation Threat Reduction, which supports both the Science Centers and Bio-Redirect nonproliferation programs working in Eurasia. BII works as part of a coordinated effort with the Department of Health and Human Services (DHHS), Department of Agriculture (USDA), and the Environmental Protection Agency (EPA).

Implementation Network

Includes:

-- The Center for Innovative Medicine and Integrated Technology (CIMIT);

-- The Civilian Research and Development Foundation (CRDF); and

-- The International Science and Technology Center (ISTC).

Accelerating Vaccine Development

In close cooperation with the Biotechnology Engagement Program (BTEP) of the U.S. DHHS [Department of Health and Human Services], BII identified a novel vaccine platform technology, currently being validated through a BTEP sponsored project at the State Research Center of Virology and Biotechnology VECTOR (Koltsovo, Novosibirsk region). BII organized an independent technical validation of the HIV-1 vaccine in collaboration with Dr. Jeffrey Gelfand of Massachusetts General Hospital/CIMIT, Dr. Barton Haynes of Duke University Medical Center's Human Vaccine Institute, and Dr. Richard Markham of Johns Hopkins University. Initial in vitro testing supports Vector's data, indicating broad reactivity to HIV-1. In addition to these initial results, BII has organized contact between the inventor and Wyeth Vaccines as well as Aventis Pasteur, both leading the race to develop a vaccine against the AIDS virus. Based upon positive technical and market feedback, BII has supported a strategic patent filing to extend Vector's proprietary approach beyond applications for HIV to include infectious diseases such as Hepatitis C and Influenza.

This work represents a model activity for BII's accelerated drug and vaccine program. BII continues to support a variety of such activities, including a extensive program on multi-drug resistant tuberculosis in Russia.